BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXGUARD PRE-SLIT INJECTION PORT

    MDR report key: 3212344 · Received July 8, 2013

    Report

    Report Number
    3212344
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 15, 2013
    Report Date
    June 11, 2013
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT ARRIVES TO INFUSION FOR CHEMO. RIGHT CHEST PORT HAD BEEN ACCESSED IN INTERVENTIONAL RADIOLOGY PER PATIENT ACCOUNT. THE INFUSION CAP WAS FOUND TO HAVE RESIDUAL BLOOD POOLED WITHIN THE INFUSION CAP. THE CAP WAS CHANGED PRIOR TO INFUSION. THIS PARTICULAR INFUSION CAP IS EXTREMELY DIFFICULT TO PROPERLY FLUSH, FREE OF BLOOD; THIS MAY POSE AN INFECTION RISK.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?CHEMOTHERAPY INFUSION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311839 MAXGUARD PRE-SLIT INJECTION PORT SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION * 13035456

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR